The Hindu Business Line : Meet against generic AIDS drugs may hurt pharma majors

THE Doha Declaration, a virtual global treatise that put health on top of the agenda for Governments, may just be shaken from its roots on Monday. An old battle will be re-visited in Botswana next week, when the merits of generic anti-AIDS drugs are going to be put through the grind yet again.

Indian pharma majors Cipla and Ranbaxy sell their anti-AIDS drugs in African markets and stand to be impacted by this meeting despite the endorsement of their anti-AIDS drugs by the World Health Organisation (WHO).

Expressing concern over the US-initiated conference on Fixed-Dose Combination (FDC) drugs, slated for March 29 and 30, to discuss issues of safety and efficacy, non-governmental organisations (NGOs) allege that "the meeting has been shrouded in secrecy and multinationals would seek to arm-twist countries into not buying generic drugs."

Given that US lobbyists have made it clear that no funds would be forthcoming if African countries would purchase FDC anti-AIDS drugs, Cipla's Joint Managing Director Mr Amar Lulla said: "It is up to individual countries to stand up and be counted. The anti-FDC AIDS drugs argument is redundant, as they are endorsed by the WHO."

For Cipla it will be déjà vu, a case of been there and done that, as about three years ago Cipla had unsettled MNCs selling in Africa by offering anti-AIDS drugs at one-thirtieth the original price.

This time around, Cipla's representatives will not be in Botswana, but Cipla supporter, Mr Bill Haddad, a generic drug manufacturer who volunteered three years ago to help Cipla's Dr Yusuf Hamied organise the campaign to reduce the price of AIDS medicines, will be there.

Ranbaxy's HIV Project Head, Mr Sandeep Juneja, said representatives from the company's South African base would represent the company at Botswana.

Mr Juneja feels that the campaign to retain turf was expected as "generics have the potential to affect the business of originator companies (who originally made the medicine)."

Pointing out the innovation done by Indian companies on the AIDS drugs, he said, "A fixed-dose combination (FDC) involves taking one pill twice a day, as opposed to taking three pills in the morning and evening, respectively. The three individual drugs are made by different companies, but we innovated to have the FDC. The benefits of FDC are that it reduces the number of pills an individual has to take and enhances the chance that patients stick to their regimen. If patients do not take their pills on time or in the right dosage, it creates the dangerous situation of drug resistance. And these were the reasons why WHO and NGOs such as Medecins Sans Frontieres endorsed our drugs."

The Botswana meeting would see the participation of UN agencies, WHO and US government representatives, and Ranbaxy's Mr Juneja feels that FDCs will only come out stronger from the debate.

Analysts say the export of anti-AIDS drugs to Africa from India would be about Rs 50 crore, but the potential is about $300 million per annum (about Rs 13,000 crore). Only last year, former US President Mr Bill Clinton struck a deal with a clutch of Indian companies to supply select anti-AIDS drugs at $140 per year per patient. Other generic anti-AIDS drugs are priced at about $300 per year, and even this is less than the estimated cost of $562 for the same combination of drugs, but in a dosage of six pills, made by brand-name companies, point out NGOs.

Ms Joanne Carter with Washington-based advocacy organisation Results International told Business Line that NGOs would be at Botswana in full-strength to support generics. "There is concern that the US government may look to push US FDA regulatory standards on anti-AIDS drugs sold in Africa. This would undermine global trade meetings that have sought to prioritise health. This meeting would put pressure on countries accessing funds, forcing them to use it in a way that would not save the most number of lives."

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